Long-Term Efficacy and Safety of Ralinepag

Condition: Pulmonary arterial hypertension

Eligibility

Key Inclusion Criteria

  • Completed the protocol-defined end-of-study (EOS) procedures and EOS visit in the original ralinepag study
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
  • Both male and female participants agree to use a medically acceptable method of contraception

Key Exclusion Criteria

  • Prematurely discontinued the study drug in the original ralinepag study or who did not complete all procedures in the original study
  • Withdrew consent during participation in another ralinepag study
  • Participants who wish to become pregnant or who have a positive pregnancy test on Day 1 of the study

Full Study Name

A Phase III Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH) (IRB no. 55258)    

Summary
This study focuses on individuals with pulmonary arterial hypertension (PAH) who have previously participated in another study with an investigational drug called ralinepag. PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. The purpose of the study is to evaluate the long-term effects of ralinepag on the participant's symptoms of PAH, ability to exercise, heart rate recovery (how quickly the heart rate slows down after a walking test) and quality of life. The study will also examine the long-term effects of ralinepag, when used with the patient's current treatment for PAH, on blood test results and study assessments as well as evaluate any side effects.

Phase
Phase III

Principal Investigator
Aaron Weinberg, MD

Contact
Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org